XT-THRIVE®
DMSO-free, Chemically Defined, Safe & Effective Cryopreservation Solution
XT-Thrive® is a DMSO-free, serum-free, protein-free, and chemically defined cryopreservation media for the preservation of mammalian cells at ultra-low temperatures (-70° C to -196° C). Designed and manufactured with the utmost quality in mind, XT-Thrive® is tailored to provide high cell recovery and functionality. It is a non-toxic & hyper-effective alternative to traditional cryopreservatives and is plug and play for cell & tissue manufacturing processes.
Organ Transplant
Not Enough Time
Do you know 80% of transplantable organs end up NOT being transplanted today, especially for hearts and lungs?
90%
1/hour
Die on waitlist
80%
transplantable organs left unused
Just hours
to keep organs alive
In organ transplantation, we are racing against TIME on Ice every day, battling an extremely slim window where every minute matters. We currently perfuse and store an organ in preservation solution that is kept between 2-8°C in an igloo cooler on wet-ice. This only allows organ survival for less than a day. For the heart, that is an ephemeral 4 hrs. This extremely tight race severely hinders organ accessibility, breeds extreme risk, creates a logistics nightmare for the transplant team and significantly impacts patient survival.
To win such a race, we MUST remove TIME from the equation.
With X-Therma’s biopreservation breakthroughs, we make a difference.
cGMP CELL & GENE THERAPY
DMSO and Serum No Longer Meet Integrated Demands
Poor Performance
- Poor post-thaw cell survival as low as 15-20%
- Cell functionality impaired
Toxic
- Profound in vivo toxicity
- Severe injection site pain/neurotoxicity
- Adverse Genotoxicity
Nature, Scientific Reports volume 9, Article number: 4641 (2019)
Hindered Scalability
- Processing nightmare
- Limited scale-up production
- Batch variation
Biopreservation is the key for commercial cell manufacturing & processing, which happens 3-5 times throughout the process. However, preservation has seen little improvement. Existing standards use 5-10% dimethyl sulfoxide (DMSO) with serum. A new solution is needed to enable “off-the-shelf” living medicines.
In Vitro Fertilization
Can we say “No” to toxins for healthy babies?
DMSO
Adverse Toxicity & Genotoxicity
Poor Functional Recovery <10% (human eggs)
In Vitro Fertilization uses a high concentration of toxic vitrification media to freeze eggs or embryos that can kill a cat just in one teaspoon taken orally. This causes severe cell shrinkage and damage to the cell membrane, ultimately leading to a negative impact on the viability of the eggs, giving less than 10% with functional recovery.
The extreme changes in microRNAs and alterations in the epigenetic landscape indicate that DMSO is not inert. Its use should be reconsidered, especially for preservation of embryos and oocytes, since it may impact embryonic development.
Nature, Scientific Reports volume 9, Article number: 4641 (2019)
cGMP CELL & GENE THERAPY
DMSO and Serum No Longer Meet Integrated Demands
Poor Performance
- Poor post-thaw cell survival as low as 15-20%
- Cell functionality impaired
TOXIC
- Profound in vivo toxicity
- Severe injection site pain/neurotoxicity
- Adverse Genotoxicity
Nature, Scientific Reports volume 9, Article number: 4641 (2019)
HINDERED SCALABILITY
- Processing nightmare
- Limited scale-up production
- Batch variation
Biopreservation is the key for commercial cell manufacturing & processing, which happens 3-5 times throughout the process. However, preservation has seen little improvement. Existing standards use 5-10% dimethyl sulfoxide (DMSO) with serum. A new solution is needed to enable “off-the-shelf” living medicines.
cGMP CELL & GENE THERAPY
DMSO and Serum No Longer Meet Integrated Demands
Poor Performance
- Poor post-thaw cell survival as low as 15-20%
- Cell functionality impaired
Toxic
- Profound in vivo toxicity
- Severe injection site pain/neurotoxicity
- Adverse Genotoxicity
Nature, Scientific Reports volume 9, Article number: 4641 (2019)
Hindered Scalability
- Processing nightmare
- Limited scale-up production
- Batch variation
Biopreservation is the key for commercial cell manufacturing & processing, which happens 3-5 times throughout the process. However, preservation has seen little improvement. Existing standards use 5-10% dimethyl sulfoxide (DMSO) with serum. A new solution is needed to enable “off-the-shelf” living medicines.
In Vitro Fertilization
Can we say “No” to toxins for healthy babies?
DMSO
Adverse Toxicity & Genotoxicity
Poor Functional Recovery <10% (human eggs)
In Vitro Fertilization uses a high concentration of toxic vitrification media to freeze eggs or embryos that can kill a cat just in one teaspoon taken orally. This causes severe cell shrinkage and damage to the cell membrane, ultimately leading to a negative impact on the viability of the eggs, giving less than 10% with functional recovery.
The extreme changes in microRNAs and alterations in the epigenetic landscape indicate that DMSO is not inert. Its use should be reconsidered, especially for preservation of embryos and oocytes, since it may impact embryonic development.
Nature, Scientific Reports volume 9, Article number: 4641 (2019)
With X-Therma’s biopreservation breakthroughs, we make a difference.
Our Solution
XT-Thrive® enables non-toxic cryopreservation for life-saving regenerative medicines such as vaccines, cell & gene therapies, and engineered tissues.
Benefits of XT-Thrive
DMSO-FREE AND NON-TOXIC
XT-Thrive® is a non-toxic and non-genotoxic cryopreservation solution that reduces the risks of adverse alterations in cellular phenotype during preservation and clinical side effects during and after cell therapy.
Chemically Defined
XT-Thrive® is a fully chemically defined formulation and contains no serum or recombinant proteins.
Uncompromised Performance
XT-Thrive® doesn‘t compromise on performance despite lacking DMSO. It is designed to preserve the viability, physical integrity, and ultimately the functionality of cells post-thaw after storage at -70° C or in liquid nitrogen.
Optimized Process For scale
XT-Thrive® enables a significant extension in the allowable timeframe for pre-freeze and post-thaw incubation. And unlike DMSO, no wash-out is required.
Plug and Play Integration
XT-Thrive® is extremely process-friendly and can be directly plugged into current workflows without requiring specialized instrumentation. It can directly replace the cryopreservation solutions that contains DMSO and/or serum.
Fields of Application of XT-Thrive®
XT-Thrive® has been validated by third parties in the following key therapeutic cells.
Cryopreservation Solution for Mammalian Cell Lines
HEK293, Jurkat, K562, TF-1, HL-1, HEPG-2, CHO, U2OS
Cryopreservation Solution for Mammalian Primary Cells
PBMCs, T Cells, CAR-T Cells, B Cells iPSCs, iPSC-derived cardiomyocytes BM and BM-derived HSCs and MSCs Cord Blood and Cord blood-derived HSCs and MScs Organoids
Cryopreservation Solution for Tissues
Full-thickness skin grafts Articular Cartilage
“XT-Thrive® reagents resulted in significantly improved viability of MSCs before freezing and post-thaw when the cells were kept at room temperature for hours, especially if the cells were cultured in serum-free media. This is a huge advantage in the manufacturing process, especially in the process of filling and transportation.”
– Steve Oh, PhD, Alan Lam, PhD, and Simon Cool, PhD
Agency for Science, Technology and Research, Singapore
XT-Thrive® Performance Tests
Resilience in an Intense Manufacturing and Uncontrolled Clinical Environment
It is generally recommended that the pre-freeze and post-thaw contact time for DMSO is limited to 30 seconds and 1-2 hours respectively; this ensures enhanced product quality. Prior to freezing, human mesenchymal stromal cells (MSCs) cultured in serum-free media in a monolayer format were exposed to different cryoprotectants. XT-Thrive® remained remarkably non-toxic, with a ~30% higher viability despite extended incubation times up to 24 hours when compared to Competitor C10. Demonstrating superior resilience post-thaw, previously frozen MSC monolayers were thawed and exposed to different cryoprotectants at room temperature for 2-6 hours. XT-Thrive® continued to remain remarkably non-toxic to MSC monolayers and maintained the ~30% higher viability despite incubation up to 6 hours while at room temperature compared to Competitor C10.
High-Efficiency Nucleofection of Primary T Cells
In collaboration with a current customer, CD4/8 cells were isolated from leukopaks and cryopreserved in XT-Thrive®. After 7 days, cells were thawed, allowed to rest overnight, and activated. After culture, nucleofection was performed on day 11 and flow analysis on day 18. Preservation in XT-Thrive® ensured a 90% nucleofection efficiency compared to a 78% efficiency when preserved in a leading DMSO solution. On day 7 post-thaw nucleofection, cells preserved in XT-Thrive® retained a ~80% nucleofection efficiency compared to ~65% in DMSO.
Compatible with Large Scale Production Processes
Serum-free growth conditions are highly desirable in cGMP cell manufacturing but are often hindered by slower cell growth rates and other issues. MSCs were frozen for 1 week in LN2, and expanded in a serum-free solution. After thawing, cells were continuously cultured for 6 days. A 2.5-fold higher growth rate (purple) was seen at 6 days after freeze/thaw with XT-Thrive® in a serum-free 3D microcarrier culture compared to DMSO.Preserved Cellular Function of Sensitive Cell Types
iPSC-derived cardiomyocytes often suffer from freezing injury with viability as low as 15% and take several days of culture to resume pacing. iPSC-derived cardiomyocytes stored in XT-Thrive® demonstrated not only high post-thaw viability (green, live cells), but also exhibited rapid recovery of original contractile function when compared to DMSO.
Preserve more of the ‘True Stem Cells’ for Bone Marrow Transplant
In collaboration with the Vitalant Research Institute, patient whole bone marrow was preserved with XT-Thrive® and field standard 10% DMSO plus 90% human serum albumin. The immediate post-thaw survival was comparable between both groups. On Day 3, the XT-Thrive® group shows >2X higher cell count for CD34+ and CD34+/CD133+ cells in comparison to the field standard solution. The in vivo transplant study can be found in the Nature subjournal, Bone Marrow Transplantation.